Measures of biosimilarity in monoclonal antibodies in oncology: The case of bevacizumab
En prenant l'exemple du bevacizumab, cet article analyse les forces et les faiblesses des modèles précliniques et cliniques permettant d'évaluer le degré de biosimilarité des anticorps monoclonaux utilisés en oncologie
Biosimilars have been available on the European market since 2006 and experience with their use is increasing. The next wave of biopharmaceuticals that are about to lose patent protection consists of more-complicated products, including many monoclonal antibodies. Guidance has been released on the particulars of a biosimilarity exercise involving these products. Considerable challenges are posed by anticancer products and there is ongoing controversy regarding which basis to establish biosimilarity for such products. An especially challenging product is bevacizumab (Avastin®). Based on data available for the innovator product (bevacizumab) we will discuss strengths and weaknesses of preclinical and clinical models and explore the application of novel endpoints to the biosimilar comparability exercise.
Drug Discovery Today , résumé, 2012